IVD-D compliant clinical diagnostic kits

ESA Analytical Ltd. have announced that all their clinical HPLC diagnostic kits including Plasma-free Metanephrine analysis, Urinary Metanephrine analysis, Fractionated Urinary Catecholamines and simultaneous determination of Urinary VMA, 5HIAA and HVA are now compliant with the In-Vitro Diagnostics Directive (IVD-D).

For each kit ESA is able to provide a complete audit trail as to how the kits are put together and provide full details of the constituent components. Each ESA kit contains all the components necessary for the respective sample preparation plus the standards and mobile phase for HPLC separation.

ESA is now uniquely able to provide Clinical laboratories with fully validated system solutions comprising IVD-D compliant HPLC diagnostic kit and analyser system, the CE marked CouloChem III HPLC electrochemical detector system from a single source.